Kornimate/medical-research-clean huggingface dataset:
bevacizumab against recurrent retinal detachment

Conditions: Retinal Detachment; Proliferative Vitreoretinopathy

Summary: the investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * eyes with rhegmatogenous retinal detachment exclusion criteria: * presence of pvr * need for a procedure other than primary ppv such as a scleral buckle with or without ppv, laser retinopexy, or pneumatic retinopexy. * recent intravitreal injection of an anti-vegf agent less than 3 months prior * secondary retinal detachment repair * use of silicone oil as tamponade agent * patients less than 18 years of age * pregnancy * known allergy or contraindication to intravitreal bevacizumab

Keywords: retinal detachment proliferative vitreoretinopathy
clinical investigation of a new bulk fill composite resin in the restoration of posterior teeth

Conditions: Dental Restoration Failure of Marginal Integrity; Dental Caries; Unrepairable Overhanging of Dental Restorative Materials; Poor Aesthetics of Existing Restoration; Secondary Dental Caries Associated With Failed or Defective Dental Restorations; Fractured Dental Restorative Materials Without Loss of Materials; Fracture of Dental Restorative Materials With Loss of Material

Summary: polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). to minimize the effects of polymerization shrinkage in the restorative treatment, the 3m espe company has developed a composite resin called filtek bulk fill posterior restorative. its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. this clinical trial is designed to evaluate the performance of the new bulk fill composite resin in class ii (two-surface posterior) fillings.


Eligibility criteria:
inclusion criteria: * be 18 years of age and older * have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment * be capable of giving written informed consent. exclusion criteria: * have a self-reported history of any adverse reaction to materials of the types to be evaluated * have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.

Keywords: adult dental care
clinical study of ta-650 in pediatric patients with crohn's disease

Conditions: Pediatric Crohn's Disease

Summary: the purpose of this study is to evaluate the efficacy of ta-650 using pediatric crohn's disease activity index (pcdai) in pediatric patients with moderate to severe crohn's disease after ta-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. the safety and pharmacokinetics are also evaluated.

this is an open-label, uncontrolled, multicenter phase 3 study conducted in japan.

Eligibility criteria:
inclusion criteria: * patients who have been diagnosed as crohn's disease at least 3 months prior to screening. * have active crohn's disease despite adequate conventional therapy. exclusion criteria: * patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery. * patients who have a history of treatment with infliximab, or biological products (anti-tnfα agents and anti-il-6 agents, etc.).

Keywords: infliximab remicade ta-650 pediatric crohn's disease
functional vision in tbi

Conditions: Brain Injuries; Visually Impaired Persons

Summary: the objective of this study is to test functional vision outcome measures that reflect the loss in everyday life tasks that require vision and that are sensitive to changes after a course of vision rehabilitation in veterans/participants with tbi.

traumatic brain injury (tbi) can cause vision loss because of diffuse or focal neuronal injury. vision can be compromised because of local injury to one or both optic nerves, diffuse brain injury, and/or limitation in eye movements because of dysfunction of cranial nerves. these typical injuries may compromise any of the neural pathways that subserve afferent or efferent visual function. self-reports of vision loss include diplopia, visual field loss, light sensitivity, reading problems and contrast sensitivity (color and luminance) loss. this project will pursue the following aims: 1) identify the relationship between functional vision loss in everyday vision tasks (reading, visual search, way finding) and the characteristics of potential visual impairment (visual acuity, contrast sensitivity, visual fields, stereoacuity, eye movement disorders) associated with tbi; and 2) determine the ability of the vision rehabilitation interventions (both monotherapy and combination therapy) to improve functional vision outcome measures that reflect everyday visual tasks. the vision rehabilitation interventions incorporated into this study will be vision restoration therapy, nvt eye scanning therapy, and standard eccentric viewing training. these therapies are rehabilitative interventions prescribed for veterans in polytrauma rehabilitation centers, blind rehabilitation centers, and advocated for va medical center tbi clinics.

Eligibility criteria:
inclusion criteria: * tbi (any form) * hemianopic visual field loss * stable fixation * 1.0 logmar or better reading acuity * 20 words per minute or better reading rate exclusion criteria: * visual neglect * medical conditions that prevent sitting for 30 minutes or following instructions

Keywords: visual perception vision, ocular neuronal plasticity
electrolysis in patients with low back pain

Conditions: Low Back Pain

Summary: the goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. the main questions it aims to answer are: the high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (ppt) changes in myofascial trigger points in the low back during the intervention compared with dry needling. percutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.

a parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (hipe), low-intensity percutaneous electrolysis (lipe), and dry needling (dn) applied to the multifidus muscle most active mtrp in subjects with low back pain. this clinical trial will follow the consolidated standards of reporting trials for pragmatic clinical trials. this procedure consists of three trials, i.e., (1, hipe) 660 ua x 30"; (2, lipe) 220ua x 30"; and (3, dn) with 1 twitch response, and the needle inserted 30".

Eligibility criteria:
inclusion criteria: * to report low back pain of at least six months duration, * aged 35 to 50 years, * at least one active trigger point is present in the multifidus muscle. exclusion criteria: * pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study, * needle fear, * prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).

Keywords: low back pain multifidus muscle trigger points shear-wave elastography pain sensitivity
trial of r-gemox regimen in previously untreated elderly patients with dlbcl.

Conditions: Diffuse Large B-cell Lymphoma

Summary: the purpose of this study is to investigate efficacy and safety of gemox(gemcitabine and oxaliplatin) combination with rituximab(r) as first-line treatment of elderly patients with dlbcl

previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (r-gemox) achieved high efficacy with a low toxicity profile in relapsed and refractory dlbcl. this regimen might be considered a putative treatment option for elderly patients. to our knowledge, the efficacy and safety of r-gemox when given as first-line therapy in elderly patients with dlbcl remains unknown. the investigators therefore developed a two-weekly regimen of rituximab combined with gemox regimen as first line treatment in elderly dlbcl and investigate its efficacy and safety. primary outcome measures: * overall response rate secondary outcome measures: * progression free survival * overall survival * safety and toxicity enrollment: 60 study start date: august 2012 primary completion date: dec 2015

Eligibility criteria:
inclusion criteria: 1. histologically confirmed cd20-positive dlbcl (the germinal center b-cell like (gcb) / non-gcb subtype was determined by immunohistochemistry in paraffin-embedded tissue using cd10, bcl6 and mum1 protein markers based on hans's algorithm); 2. new-diagnosed and untreated; 3. age older than 70 years or older than 60 years with ecog ps ≥2; 4. understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. exclusion criteria: 1. poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration; 2. poor cardiac function greater than grade ii according to new york heart association functional classification; 3. presence of grade iii nervous toxicity over two weeks; 4. hepatitis b virus (hbv) load (hbv dna) more than 1×105 copies/ml; 5. concomitant malignancy other than dlbcl requiring treatment; 6. concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial; 7. contraindication to any drug in this regimen; 8. active and severe infectious diseases, such as severe pheumonia or septicaemia; 9. major surgery within three weeks; 10. any medical, psychological or social conditions which might interfere with the investigators' assessment 11. in any conditions which investigator considered ineligible for this study.

Keywords: rituximab gemcitabine oxaliplatin diffuse large b-cell lymphoma
does cognitive impairment affect rehabilitation outcome in parkinson's disease?

Conditions: Parkinson's Disease

Summary: in order to explore the question how an intensive, goal-based and aerobic rehabilitation treatment, addressed to act on motor and mental aspects, affects motor and functional symptoms in pd patients with normal cognition and with different level of cognitive impairment. hypothesis is that a specific rehabilitation program based on motor-cognitive training and repetition, can affect positively the rehabilitation outcome regardless of baseline cognitive profile.

objective: this study is aimed to evaluate the impact of cognitive decline on rehabilitation outcomes in parkinson's disease (pd). while cognitive status is considered as a determinant of rehabilitation outcome, no studies about this issue have been performed before. methods: 438 pd patients hospitalized for a 4-weeks multidisciplinary intensive rehabilitation treatment (mirt) were enrolled. according to mini mental state examination (mmse), patients were divided into: normal cognition (mmse 27-30), mild cognitive impairment (mmse 21-26), moderate or severe cognitive impairment (mmse ≤ 20). according to frontal assessment battery (fab), subjects were divided into patients with normal (fab ≥ 13.8) and pathological (fab \< 13.8) score. the outcomes measures were: unified parkinson's disease rating scale (updrs), berg balance scale (bbs), timed up and go test (tug), six minutes walking test (6mwt), parkinson's disease disability scale (pdds).

Eligibility criteria:
inclusion criteria: * parkinsonian patients according to the uk brain bank criteria exclusion criteria: * major stroke, possible hydrocephalus or brain tumor observed on ct scan or brain mri * major depression, active psychosis or clinically significant psychiatric disorders * visual or auditory disturbances that prevent the neuropsychological assessment * the increase in drug dosage during hospitalization

Keywords: cognition impairment rehabilitation parkinson's disease
development and validation of a clinical risk prediction model for early acute kidney injury within 48 hours after liver transplantation

Conditions: Acute Kidney Injury; Liver Transplantation; Model

Summary: acute kidney injury (aki) is a common complication after liver transplantation, with an incidence of 12.7-95%. the occurrence of acute kidney injury after transplantation is related to the poor prognosis of patients, which significantly increases the length of hospital stay, hospitalization costs and mortality of patients. early recognition of acute kidney injury after transplantation is of great significance. therefore, by collecting preoperative and intraoperative variables, this study intends to establish and verify a clinical risk prediction model for early aki after liver transplantation, in order to provide clinicians with a visual prediction tool to identify patients with high risk of early aki after liver transplantation immediately after the operation, so as to start clinical intervention as soon as possible and improve the prognosis of patients.


Eligibility criteria:
inclusion criteria: * patients who underwent liver transplantation in beijing tsinghua changgung hospital. exclusion criteria: * (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (rrt) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.

Keywords: acute kidney injury, liver transplantation, model, validation
viaskin pertussis vaccine trial

Conditions: Whooping Cough

Summary: the study is a phase i, first in human, monocenter study, aiming at assessing the safety and immunogenicity of a genetically detoxified pertussis toxin (pt) when administered via the cutaneous route with viaskin patches to healthy volunteers at 2 different doses of 25 mcg or 50 mcg pt protein compared to viaskin placebo. two cohorts of 30 subjects will be successively enrolled. safety of the product will be assessed throughout the 10-week study and its immunogenicity will be assessed at regular intervals with collection of blood samples for immunological analyses. four weeks after the second viaskin application (at day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (boostrix® dtpa) to ensure the optimal recall of their immunity against pertussis.


Eligibility criteria:
inclusion criteria: * has provided written informed consent before enrollment; * adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment; * non-pregnant, non-lactating female; * free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening; * with documented history of pertussis immunization (at least 4 doses); * women of childbearing potential with a negative pregnancy test at entry; * females of childbearing potential who are willing to use an effective method of contraception. exclusion criteria: * prior dtpa immunization within the last 10 years or prior dt immunization within the last 2 years, or any other investigational vaccine likely to impact on interpretation of the trial data; * suspected or confirmed pertussis infection within the last 10 years or documented pertussis infection in a household member within the last 10 years; * receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial.

Keywords: pertussis epicutaneous immunotherapy (epit) vaccine viaskin pt
stroke volume variation and pulse pressure variation as predictors of fluid responsiveness during kidney transplantation

Conditions: Kidney Transplantation

Summary: the aim pf this prospective study is to investigate the ability of stroke volume variation (svv) and pulse pressure variation (ppv) to predict fluid responsiveness in patients undergoing kidney transplantation.

optimal intraoperative fluid management guided by central venous pressure (cvp), a traditional intravascular volume status indicator has been established to improve transplanted graft function during renal transplantation. recently, stroke volume variation (svv) and pulse pressure variation (ppv), dynamic preload indices derived from the arterial waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized patients and critically ill patients. however, their usefulness in renal failure patients undergoing renal transplantation has not been investigated. thus, the aims of this study is to investigate accuracy of svv and ppv for predicting fluid responsiveness in patients undergoing kidney transplantation.

Eligibility criteria:
inclusion criteria: - chronic renal failure patients undergoing renal transplantation exclusion criteria: * patients with cardiac arrhythmia * patients with reduced left ventricular function (ef \< 40%) * patients with valvular heart disease * patients intracardiac shunt * patients with pulmonary hypertension * patients with extensive peripheral vascular disease * patients with preoperative use of vasopressors or inotropics

Keywords: fluid responsiveness pulse pressure variation stroke volume variation
the reversal intervention for metabolic syndrome study

Conditions: Metabolic Syndrome

Summary: the aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future.

people who have a combination of risk factors termed metabolic syndrome are at increased risk of developing diabetes, heart disease and strokes. metabolic syndrome is a major public health concern requiring urgent action because 25% of the adult uk population fulfil the criteria, and this will increase as people continue to be less active and levels of overweight and obesity rise. the aim of our study is to see if people with metabolic syndrome who attend a structured group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes and cardiovascular disease in the future. overall, we hope to show that this type of education reduces the number of people who have metabolic syndrome. subjects recruited with metabolic syndrome will be randomised to intervention or control arms. the intervention arm will receive group education and the control group will receive routine care. the results will inform primary prevention strategies in people from varied ethnic backgrounds who are at high risk of developing type-2 diabetes and cardiovascular disease.

Eligibility criteria:
inclusion criteria: * aged 40 - 74 years inclusive * registered with a general practice in leicester city or leicester county primary care trust * availability of data to allow diagnosis of mets (idf criteria) collected at a screening visit exclusion criteria: * previous diagnosis of t2dm, cvd (stroke/cerebrovascular accident, transient ischaemic attack), peripheral arterial disease, or coronary heart disease (angina, myocardial infarction, coronary artery bypass surgery, angioplasty) * life-limiting terminal illness * pregnancy and/or breast feeding * lack of capacity to give informed consent because of serious mental health problems or learning disability. * people who are housebound * patients residing in nursing/care homes * individuals who are unable to speak and understand english. (the intervention will be made appropriate for ethnically diverse populations, but individuals who are unable to understand, speak and read english will be excluded at this stage. however, if the self-management programme is found to be successful we would adapt it for non-english speakers.)

Keywords: metabolic syndrome primary prevention diabetes cardiovascular disease patient education
aptima hpv 16 18/45 genotype assay on the tigris dts system in women with asc-us or negative pap test results

Conditions: Human Papillomavirus Infection

Summary: in both the asc-us study and adjunct study populations, the objectives are to: * evaluate the performance characteristics of the ahpv-gt assay for detecting cervical disease in women with aptima hpv assay positive results and * evaluate the ability of the ahpv-gt assay to detect hpv high-risk types 16, 18, and 45 in women with aptima hpv assay positive results.

the aptima hpv 16 18/45 genotype assay (ahpv-gt assay) is an in vitro nucleic acid amplification test for the qualitative detection of e6/e7 viral messenger rna (mrna) of human papillomavirus (hpv) types 16, 18 and 45 in cervical specimens from women with positive results in the aptima hpv assay. the ahpv-gt assay can differentiate between samples positive for hpv 16 from those positive for hpv 18 and/or 45, but does not differentiate between hpv 18-positive samples and hpv 45-positive samples. cervical specimens collected in thinprep pap test vials containing preservcyt solution (hologic, inc., marlborough, massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination) may be tested with the ahpv-gt assay either pre- or post-pap processing. the assay is used with the tigris dts (tigris) system. in both the asc-us study and adjunct study populations, the objectives are to: * evaluate the performance characteristics of the ahpv-gt assay for detecting cervical disease in women with aptima hpv assay positive results and * evaluate the ability of the ahpv-gt assay to detect hpv high-risk types 16, 18, and 45 in women with aptima hpv assay positive results.

Eligibility criteria:
inclusion criteria: * • the subject attended a colposcopy visit, and * the referral pap sample had a valid aptima hpv assay result, and * the sample had an aptima hpv assay positive result, or * the sample had an aptima hpv assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (cin) grade 2 \[cin2\] or more severe (eg, cin2, cin grade 3 \[cin3\], or cervical cancer; "cin2+"), or * the sample had an aptima hpv assay negative result and the subject had a consensus histology result of normal or cin grade 1 (\<cin2) and was randomly selected for inclusion. the referral pap sample had a valid aptima hpv assay result, and * the sample had an aptima hpv assay positive result, or * the sample had an aptima hpv assay negative result and the subject had a consensus histology result of cin2+, or * the sample had an aptima hpv assay negative result and the subject had a consensus histology result of \<cin2 and was randomly selected for inclusion. exclusion criteria: * samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the ahpv-gt assay if there is insufficient volume for ahpv-gt assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).